Memo Therapeutics AG (MTx) has announced the completion of patient enrollment in its Phase II clinical trial for potravitug, a BK polyomavirus (BKV)-neutralizing antibody. The trial, conducted across 22 sites in the U.S., focuses on kidney transplant patients who are at risk of BK viremia.
The randomized, double-blind, placebo-controlled study aims to evaluate the safety, tolerability, and efficacy of potravitug. Topline data is expected in mid-2025. This progress marks a significant milestone as there are currently no disease-modifying treatments available for BK viremia.
Addressing a Critical Unmet Need
BK viremia poses a substantial threat to kidney transplant recipients. More than 100,000 kidney transplants are performed globally each year, and BKV can reactivate in up to 50% of these patients. Approximately 10% may develop BK polyomavirus-associated nephropathy (BKVAN), which significantly increases the risk of kidney loss and patient mortality.
"There are currently no disease modifying treatments available for BK viremia, so this clinical progress is a great milestone for both the field and Memo Therapeutics AG," said Erik van den Berg, CEO of MTx. He also expressed his anticipation for the results and subsequent discussions with stakeholders regarding potential approval pathways.
Trial Design and Fast-Track Designation
The Phase II trial, known as SAFE KIDNEY II, has enrolled 90 participants and is the largest placebo-controlled study ever conducted for the treatment of BK viremia in kidney transplant recipients. Potravitug received fast-track designation from the U.S. Food and Drug Administration (FDA), highlighting the urgent need for effective treatments.
Potravitug: A Potential First-in-Class Therapy
Potravitug, discovered using MTx’s DROPZYLLA technology, has the potential to be a first-in-class BKV disease-modifying therapy for kidney transplant patients. The market potential for such a therapy is estimated to be over $1 billion.
"I am pleased with the progress of the Phase II clinical trial for potravitug, which has first and best-in-class potential to treat BK viremia in kidney transplantation patients, a severe infection which increases the risk for early graft loss," said Dr. David Wojciechowski, an investigator in the trial.
